FAQ's - Blood Irradiation

  • Can I use Rad Sure indicators?

    • Yes, Rad Sure indicators work well in the RS 3400 Revolution

  • Does the RS 3400 Revolution have ISBT compliant software and bar code reader?

    • Yes, the RS 3400 Revolution has ISBT compliant software and a bar code reader that comes standard with the equipment

  • Can anyone operate the Revolution (security requirements)?

    • Yes, but it is password protected by the key operator who must assign a password for data tracking purposes

  • Does the Revolution require external cooling?

    • No, the RS 3400 uses a high performance silicon oil cooler for internal cooling

  • Will the RS 3400 alert me if there are any problems with the unit?

    • Yes, there are multiple fault detectors that continuously monitor the irradiation cycle parameters

  • Is the Revolution easy to operate?

    • Yes, there is an integrated shelf for preparing and loading the canisters for easy placement into the carousel and the operator’s panel has a simple START button to initiate the cycle

  • How reliable is the unit?

    • • The 4pi emitter tube is capable of producing up to 1 megaRad per hour (1,000,000 rads) or 16,667 rads per minute. For use in the RS 3400 Revolution, it only needs to produce about 500 rads per minute or less than 5% of its capability.
    • It is the same tube as used in our RS 1300 and RS 2400 and RS 2500 high output irradiators.
    • The power supply (only one required) is designed to Military Specifications and has proven very reliable in the RS 2400 irradiators, which use the same tube and carousel as the RS 3400.

  • What is the dose uniformity?

    • The overall dose uniformity from low to high is within +/- 10% of the centerline dose

  • Can you irradiate aliquots?

    • Yes, up to a 50ml loaded syringe

  • What is the capacity (number of bags) processed at one time?

    • From 1 unit up to 5 units per cycle

  • What is the cycle time?

    • The cycle time for 1 to 5 units (whole blood bags, platelets, aliquots etc.) is about 300 seconds (5 minutes) depending upon centerline dose requested.

  • Is the RS 3400 Revolution blood irradiator cleared by the FDA for GVHD?

    • Yes, the RS 3400 was cleared by the US-FDA for marketing for the irradiation of blood for the treatment of graft verses host disease (GVHD) in January 2009

  • How does the RS 3400 Revolution differ from other X-ray irradiators?

    • • The RS 3400 is designed to have the blood bags rotate around the 4 pi X-ray tube using our patented carousel and therefore delivers superior uniformity
    • Unlike other x-ray blood irradiators, the RS 3400 Revolution is completely self-contained and requires no external water supply for tube cooling
    • The RS 3400 Revolution is engineered for extreme reliability as it uses the proven 4 pi X-ray tube and Mil-Spec power supply

  • How does the RS 3400 Revolution differ from a Cs-137 gamma irradiator?

    • The RS 3400 uses a Rad Source patented 4 pi X-ray emitter tube and therefore contains no radioactive isotopes. It can be turned on and off similar to a light bulb. As a result, there is no Nuclear Site License, Homeland Security issues, or room shielding requirements.

  • What does CDRH stands for?

    • CDRH stands for the FDA’s Center for Devices and Radiological Health (CDRH). Performance Standards for Ionizing Radiation Emitting Products can be found at CDRH 21CFR1020.40

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